Design of facilities used for controlled environments, including both sterile and aseptic environments as well as containment facilities for biological or chemical processes, is a cross-disciplinary consultancy discipline, which requires specialised knowledge of the clients product, production and processes.
Design of cleanrooms for aseptic production environments, e.g. for the production of pharmaceuticals, demands an understanding of GMP (Good Manufacturing Practise) and specialised knowledge of the rules and regulations that concern this type of production facility. Likewise, design of containment facilities for bio-pharma and chemical production demands that special requirements and circumstances are taken into account, e.g. concerning GMO (Gene Modified Organisms) and biological agents. This will, on many occasions, involve Bio Safety and Bio Security conditions.
Cleanrooms are relevant, when there is a need to create a controlled environment preventing or limiting the presence of contaminants in order to protect the product. Cleanrooms are used in order to meet certain requirements that ensure a qualified and documented production, also known as GMP (Good Manufacturing Practise). This way the cleanroom creates an aseptic environment that will only allow an acceptable level of contaminants, which would otherwise affect the product negatively. Contaminants can be microorganisms and particles but also specific chemical substances.
Containment facilities are relevant, when there is a need for a controlled environment to protect the operators and/or the surroundings. Containment facilities are used, for instance, when working with GMOs, where the surroundings need to be protected from exposure or when handling biological agents and chemical substances that could harm the operators.
Combined cleanroom and containment facilities
In certain cases there is a need for the controlled environment to meet the requirements for both a cleanroom and a containment facility. This applies to certain biotechnical processes, when producing vaccines, in the field of nanotechnology and with the production of potent pharmaceuticals, e.g. medicine for the treatment of cancer.
Designing controlled environment is often an extremely complex and interdisciplinary process. The design solutions are never safer than the weakest link. Success depends on a close cooperation between the users of the controlled environment, the consultant and relevant contractors and suppliers. It is also important to include the relevant authorities during the process. The design process itself begins with a series of detailed analyses and careful planning, which includes user involvement, e.g. when doing 1:1 mock-up tests of critical work flows and processes.
Ramboll can provide Project and Construction management along with all specialized technical disciplines through all relevant project phases of the development of your cleanroom or containment facility. This way all interfaces throughout the process, from the initial analyses and programming through Conceptual Design, Basic Design and Detailed Design to Construction and final Test and Qualification, are taken care of as a whole.
Hence, Ramboll is offering turn-key solutions for both cleanroom and containment facilities. Our The process typically looks like this:
The initial phases:
- Determining process- and work flows
- Working out rationale for room classifications and air flows
- Carry through risk assessment regarding Biosafety and Biosecurity
- Functional programming, including requirement specification for individual rooms
- Drawing up User Requirement Specifications(URS)
Design and execution:
- Design and furnishing of cleanrooms and containment facilities, making use of 1:1 mock-ups for testing critical work flows and processes e.g. cloth change procedures in air locks
- Design of technical installations, including HVAC, Electrical installations and BMS, Access control and interlock systems
- Design of process installations and utilities, for example WFI, compressed air, SIP-CIP
- Space management – 3D coordination
- Coordination of design development of process equipment
- Construction management and expert supervision
- Test and qualification
Apart from offering turn-key solutions, Ramboll can assist with a range of highly specialised consultancy services aimed at clients with existing production facilities, which are in need of upgrade and renovation:
- Compliance & GAP-analyses
- Upgrade rebuild strategies
- Human Factor Design
- EHS consultancy